[Code of Federal Regulations]
[Title 21, Volume 7]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR640.66]

[Page 98]
 
                        TITLE 21--FOOD AND DRUGS
 
          DEPARTMENT OF HEALTH AND HUMAN SERVICES--(Continued)
 
PART 640--ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS--Table of Contents
 
                        Subpart G--Source Plasma
 
Sec. 640.66  Immunization of donors.

    If specific immunization of a donor is to be performed, the 
selection and scheduling of the injection of the antigen, and the 
evaluation of each donor's clinical response, shall be by a qualified 
licensed physician or physicians. The administration of the antigen may 
be performed by a licensed physician or a trained person under his 
supervision. Any material used for immunization shall be either a 
product licensed under section 351 of the Public Health Service Act for 
such purpose or one specifically approved by the Director, Center for 
Biologics Evaluation and Research, Food and Drug Administration. 
Immunization procedures shall be on file at each plasmapheresis center 
where immunizations are performed.

[38 FR 32089, Nov. 20, 1973, as amended at 49 FR 23834, June 8, 1984; 55 
FR 11013, Mar. 26, 1990]